- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07748546
The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia
The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia: A Randomized Controlled Clinical Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Myopia is a public health issue of global concern, with its incidence and severity increasing annually, particularly among children and adolescents. Projections indicate that by 2050, the global prevalence of myopia will reach as high as 49.8%, with the prevalence of high myopia reaching 9.8% .With the rising prevalence of myopia, the risk of myopia-related complications has increased significantly, including cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Without proper management, these conditions can lead to severe visual impairment and substantial societal burdens. Therefore, preventing and slowing the onset and progression of myopia has become a critical strategy in myopia control efforts.
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. In a 12-month multicenter randomized clinical trial, the RLRL group demonstrated a 69.4% reduction in axial length elongation and a 76.6% decrease in myopic refractive progression compared to the single-vision spectacle (SVS) group. Furthermore, RLRL therapy showed superior efficacy in patients with high myopia, achieving an axial length reduction of over 0.05 mm in 53.3%-59% of cases.Comparative studies on the efficacy of atropine in controlling myopia demonstrated that, after 12 months of use, the RLRL therapy significantly outperformed 0.01% atropine in controlling axial length.In myopic patients who still exhibit poor control of axial length despite wearing orthokeratology lenses, combined use of RLRL therapy significantly inhibits axial growth.
Given that myopia typically progresses continuously during childhood, Xiong et al. investigated the long-term efficacy and safety of RLRL therapy over a period exceeding two years. The results demonstrated good tolerability of RLRL therapy, with an efficacy rate of 75% in terms of axial length reduction and myopic refractive control after two years of treatment; however, the therapeutic efficacy declined in the second year compared to the first year.Additionally, similar to other myopia intervention strategies, a rebound effect was observed in patients who discontinued RLRL treatment after one year; in these patients, their myopia progression rate during the second year was comparable to the progression level observed in the SVS group during its first year.
To further investigate the long-term efficacy of RLRL treatment and rebound effects after treatment discontinuation, as well as to explore strategies for mitigating these rebound effects, this study focused on participants who received continuous RLRL therapy for one year. It examined the rebound effects in axial length (AL) and spherical equivalent refractive power (SER) among participants who discontinued or gradually reduced RLRL treatment compared to those who continued treatment.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lixia Feng, Doctor
- Telefonnummer: +8613075590585
- E-post: lixiafeng75@fy.ahmu.edu.cn
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 8 to 16 years old
- Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
- Diagnosed with myopia (ciliary muscle paralysis SER ≥ -0.50 D), astigmatism ≤ 2.50 D, anisometropia ≤ 1.50 D, and bilateral best corrected visual acuity (BCVA) ≥ Snellen 20/20 before receiving RLRL treatment.
- The consent of the guardian and the consent of the participant.
Exclusion Criteria:
- History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
- Systemic diseases that affect vision or eye health (e.g., diabetes). After discontinuing RLRL treatment, other myopia control interventions other than monocular glasses should be employed (including atropine, orthokeratology lenses, defocused/DOT lenses, etc.).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: the continued RLRL treatment group(RLRL-C)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and continue to receive RLRL treatment for one more year.
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
|
Experimentell: the discontinued RLRL treatment group (RLRL-I)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and discontinue RLRL treatment for one year.
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
|
Experimentell: the gradually reduced RLRL treatment group (RLRL-T)
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and gradually reduce the RLRL treatment for one year(First month: twice daily, for 5 days per week;Second month: Once daily, for 5 days per week;Third month: once daily, for 3 days per week).
|
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control.
The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Axial length(AL)
Tidsram: Baseline, 6 months and12 months.
|
Change from baseline in Axial length [Unit of Measure:mm]
|
Baseline, 6 months and12 months.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Spherical Equivalent Refraction (SER)
Tidsram: Baseline, 6 Months, 12 Months
|
Mean change from baseline in spherical equivalent refraction [ Unit of Measure: Diopters (D) ]
|
Baseline, 6 Months, 12 Months
|
|
Best-Corrected Visual Acuity (BCVA)
Tidsram: Baseline, 6 Months, 12 Months
|
Change from baseline in best-corrected visual acuity measured using the ETDRS chart [Unit of Measure: LogMAR]
|
Baseline, 6 Months, 12 Months
|
|
corneal curvature
Tidsram: Baseline, 6 Months, 12 Months
|
Change from baseline in mean corneal curvature (K-readings) [Unit of Measure: Diopters]
|
Baseline, 6 Months, 12 Months
|
|
Anterior Chamber Depth (ACD)
Tidsram: Baseline,6 months and 12 months.
|
Change from baseline in anterior chamber depth (Unit of Measure:mm)
|
Baseline,6 months and 12 months.
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KY2026-03-88
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